Impact of SpHb Monitoring on Transfusion
Primary Purpose
Anemia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Continuous non-invasive hemoglobin monitoring
Sponsored by
About this trial
This is an interventional prevention trial for Anemia focused on measuring Anemia, Blood transfusion, non invasive hemoglobin monitoring, patient safety
Eligibility Criteria
Inclusion Criteria:
- ASA 1,2 patients from 15 to 60 years old scheduled for neurosurgical procedure
Exclusion Criteria:
- Exclusion criteria included significant liver or renal disease, coagulopathy, pregnancy, anemia, and patients scheduled for procedures with excepted low blood loss.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
SpHb Group.
Arm Description
Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
Continuous non-invasive hemoglobin monitoring (SpHb monitoring) was provided to the anesthesiologist to influence administration of care
Outcomes
Primary Outcome Measures
RBC Transfusions Per Subject Receiving a Transfusion
Determine whether using SpHb can affect the quantity of RBC transfused, per patient receiving a transfusion.
The Effect of SpHb on Transfusion Timeline
Length of time it takes to initiate a RBC transfusion after the need was first established.
Secondary Outcome Measures
SpHb Absolute and Trend Accuracy
To assess absolute accuracy, or single point comparison, paired SpHb and Hb measurements were compared pre- and post- transfusion and bias and standard deviation were calculated. A Bland Altman graph with limits of agreement (1.96 x standard deviation, adjusted for the bias) was plotted to show agreement across the range of values. To assess trending, a regression plot of changes in Hb and corresponding changes in SpHb was plotted and a coefficient of determination (R2) was calculated
Full Information
NCT ID
NCT01906515
First Posted
July 13, 2013
Last Updated
January 24, 2014
Sponsor
Cairo University
Collaborators
Masimo Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01906515
Brief Title
Impact of SpHb Monitoring on Transfusion
Official Title
Continuous and Noninvasive Hemoglobin Monitoring Reduces Red Blood Cell Transfusion During Neurosurgery: A Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Masimo Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Continuous and noninvasive hemoglobin (SpHb) monitoring provides clinicians with real-time trending of changes or lack of changes in hemoglobin, which has the potential to alter red blood cell (RBC) transfusion decision making. The objective of this study was to evaluate the impact of SpHb monitoring on RBC transfusions in high blood loss surgery. The investigators hypothesize that SpHb will improve blood transfusion practice in the for of change the number of blood unit per patient and improve the outcome regards the time to take decision of transfusion trigger.
Detailed Description
Eligible patients scheduled for neurosurgeries were enrolled into either a standard care group (Control Group) or an intervention group (SpHb Group). The Control Group received typical anesthesia care including estimated blood loss (EBL) assessment and intraoperative hemoglobin measurements from the central laboratory (Hb). Blood samples were taken when EBL was ≥15% of total blood volume. RBC transfusion was initiated if Hb was ≤10 g/dL and continued until the EBL was replaced and Hb >10g/dL was confirmed. The SpHb Group followed the same transfusion practice as the Control Group except the anesthesiologist was guided by the addition of SpHb monitoring with blood samples still taken pre- and post-transfusion. Additionally, the absolute and trend accuracy of SpHb compared to Hb was evaluated. Potential cost savings from reduced RBC utilization will be calculated if occured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Anemia, Blood transfusion, non invasive hemoglobin monitoring, patient safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
Arm Title
SpHb Group.
Arm Type
Experimental
Arm Description
Continuous non-invasive hemoglobin monitoring (SpHb monitoring) was provided to the anesthesiologist to influence administration of care
Intervention Type
Device
Intervention Name(s)
Continuous non-invasive hemoglobin monitoring
Other Intervention Name(s)
Masimo Radical-7 with SpHb
Intervention Description
Anesthesiologist is provided with real-time continuous non-invasive hemoglobin monitoring to influence care provided to patient
Primary Outcome Measure Information:
Title
RBC Transfusions Per Subject Receiving a Transfusion
Description
Determine whether using SpHb can affect the quantity of RBC transfused, per patient receiving a transfusion.
Time Frame
During surgery (an average of about 4 hours)
Title
The Effect of SpHb on Transfusion Timeline
Description
Length of time it takes to initiate a RBC transfusion after the need was first established.
Time Frame
During surgery (an average of about 4 hours)
Secondary Outcome Measure Information:
Title
SpHb Absolute and Trend Accuracy
Description
To assess absolute accuracy, or single point comparison, paired SpHb and Hb measurements were compared pre- and post- transfusion and bias and standard deviation were calculated. A Bland Altman graph with limits of agreement (1.96 x standard deviation, adjusted for the bias) was plotted to show agreement across the range of values. To assess trending, a regression plot of changes in Hb and corresponding changes in SpHb was plotted and a coefficient of determination (R2) was calculated
Time Frame
During surgery (an average of about 4 hours)
Other Pre-specified Outcome Measures:
Title
Potential Cost Savings
Description
Potential cost saving resulting from reduced RBC utilization was estimated using activity-based cost estimates established by Shander et al.(8) which determined from both U.S. and European hospitals the total cost of transfusing one RBC unit to be between $522 and $1,183 with a mean and standard deviation of $761 ± $294.
Time Frame
During surgery (an average of about 4 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA 1,2 patients from 15 to 60 years old scheduled for neurosurgical procedure
Exclusion Criteria:
Exclusion criteria included significant liver or renal disease, coagulopathy, pregnancy, anemia, and patients scheduled for procedures with excepted low blood loss.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wael N Awada, MD
Organizational Affiliation
Department of Anesthesia, ICU, and Pain Management, Cairo University, Egypt
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Impact of SpHb Monitoring on Transfusion
We'll reach out to this number within 24 hrs